Active Member
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[China]
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Contact name:Edward YU
Hangzhou Aichek Medical Technology Co.,Ltd |
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Saliva based Lateral Flow ag rapid Test kit point of care
| Product Name | Saliva based Lateral Flow ag rapid Test kit point of care |
| Formats | Device(4mm) |
| Place of Origen | China |
| Specimen | Saliva |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or I Test/Box |
| Storage | 2℃-30℃ |
[INTENDED USE]
The COVID-19 Antigen Home Test (Saliva) is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in saliva specimen directly from individuals within 7 days of symptom onset to suspect COVID-19 infection. The COVID-19 Antigen Home Test (Saliva) is intended for self-use or lay person testing in a non-laboratory setting.
[PRINCIPLE]
The COVID-19 Antigen Home Test (Saliva) is a qualitative membrane based chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human saliva specimen.
When specimens are processed and added to the test cassette, SARS-CoV-2 antigens, if present in the specimen, will react with the colored anti-SARS-CoV-2 antibody-coated particles, which have been precoated on the test strip. The antigen-antibody complex then migrates towards the membrane by capillary action. This complex is then captured by anti-SARS-CoV-2 monoclonal antibody immobilized at the test line region, and a colored line appears on the membrane. Test results are interpreted visually at 15~20 minutes based on the presence of the absence of visually colored lines.
To serve as a procedure control, a red line will always appear in the control line region after proper volume of specimen has been added, and membrane wicking has occurred.
